Method and apparatus for closing off a portion of a heart ventricle

ABSTRACT

Apparatus and methods to reduce ventricular volume are disclosed. The device takes the form of a transventricular anchor, which presses a portion of the ventricular wall inward, thereby reducing the available volume of the ventricle. The anchor is deployed using a curved introducer that may be inserted into one ventricle, through the septum and into the opposite ventricle. Barbs or protrusions along the anchor body combined with a mechanical stop and a sealing member hold the device in place once deployed.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. Ser. No. 12/828,974filed on Jul. 1, 2010, which is a divisional of U.S. Ser. No. 11/450,131filed Jun. 8, 2006, now U.S. Pat. No. 7,766,816, which claims thebenefit of U.S. Provisional Application No. 60/689,012 filed Jun. 9,2005; the full disclosures of which are incorporated herein by referencein their entirety.

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for temporarilyor permanently closing off a portion of the ventricle of the heart.

BACKGROUND OF THE INVENTION

In left ventricular hypertrophy, the myocardium of the left ventriclebecomes thickened to the point of interfering with effective heartcontraction. A surgical procedure for treating congestive heart failure,involves removing a triangular portion of a patient's heart. In thisoperation, approximately one-third of the patient's left ventricularmuscle is removed. The result is that the smaller heart pumps moreefficiently. This new technique of course requires open-heart surgery,with its attendant expense and extended convalescence.

One method to reduce ventricular volume is disclosed in U.S. Pat. No.6,776,754 to Wilk, which is hereby incorporated by reference in itsentirety.

For this and other potential procedures, it would be beneficial to havea method and system that could be temporarily and/or permanentlyimplanted to close off a portion of the ventricle.

SUMMARY OF THE INVENTION

The present invention relates to a catheter or surgical based systemcapable of closing off a portion of a ventricle of a patient. Theventricle may be temporarily blocked during a surgical procedure or itmay be permanently or semi-permanently closed off to improve cardiacfunction.

The present invention takes the form of an anchor for performing heartreconstruction including an elongated body, a plurality of protrusionsextending from the body, and first and second mechanical stops orsealing members attachable to the body.

The anchor of mechanical stop may include two or more folding arms. Thefolding arms may be pivotally attached to the first end of the body.

One end of the anchor may include a curved needle that forms one end ofthe anchor.

The anchor may be used with a curved introducer. The elongated bodybeing sized and configured to pass through the curved introducer.

The second sealing member may be held in place by a plurality ofprotrusions.

The sealing member may be formed of a resilient material.

A method of performing ventricular reconstruction, including the steps:(a) passing a curved needle through an anterior wall of a left ventricleof a patient; (b) passing the curved needle through the septum and intothe right ventricle; (c) inserting an anchor into the needle; (d)allowing one or more arms located on a distal end of said anchor todeploy; (e) removing the curved needle; (f) placing a sealing memberover a proximal end of said anchor; (g) folding a wall of the ventricleinward; (h) and using the sealing member to hold the folded wall inplace.

The method may include passing the curved needle through an anteriorwall of the right ventricle prior to step (d).

The method may be used to reduce the volume of the left ventricle and/orto treat left ventricular hypertrophy.

The method may include using the sealing member to hold the wall of theventricle in place by engaging one or more protrusions extending fromthe anchor.

The method using a sealing member formed of a resilient material, suchthat the sealing member is resiliently deformed, thereby resilientlypressing against the wall of the ventricle.

The method may include the step of removing a portion of the anchorafter the wall of the ventricle has been moved.

The method may be used to temporarily or permanently implant the device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C show a method and device for left ventricular reconstructionusing a left ventricular approach.

FIGS. 2A-C show an alternate procedure of FIGS. 1A-C.

FIGS. 3A-B show a method and device for left ventricular reconstructionusing a right ventricular approach.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A-1C show a method and device 100 for left ventricularreconstruction using a left ventricular approach. The device is ananchor deployment system 100, which is guided to the correct location onthe heart by introducing a hollow curved introducer or needle 102 inthrough the anterior wall of the left ventricle. A visual guidancesystem, such as TEE, may be used to ensure the placement accuracy. Thetip of the curved needle 102 is then guided through the septum and intothe right ventricle. Either before placement or once the needle 102 isin place, the transventricular anchor 104 is loaded into the needle 102.The distal tip of the anchor 104 is extended into the cavity of theright ventricle.

The distal tip of the anchor 104 has a mechanical stop 106. Although itmay take any suitable form, such as a resilient member or mechanicaldevice, in the embodiment shown, the stop 106 has two or more pivotingarms 108. While the anchor 104 is within the needle 102, the arms 108are held close to the body of the anchor 104. When the distal tip of theanchor 104 extends beyond the distal tip of the needle 102, the arms 108are free to open. The arms 108 may be biased toward the open position orthey maybe be manually opened. Once opened, the arms 108 prevent thedistal end of the anchor 104 from passing back through the opening inthe septum.

After the anchor 104 is in place, the needle 102 may be removed. Aproximal sealing lock 110 is then slid onto the proximal end of theanchor 104. The sealing lock 110 is slid along the body and over one ormore barbs 112 or other protrusions extending from the body of theanchor 104. The barbs 112 may take any suitable form, such as rounded ortriangular. In the embodiment shown, the barbs 112 are generallytriangular in shape. The proximal sealing lock 110 is advance until theanterior wall of the left ventricle is pressed inward, thereby foldingthe wall and reducing the interior volume of the left ventricle. Oncethe sealing lock 110 is advanced into place, the proximal portion of thebody of the anchor 104 may be trimmed or cut off. Although the sealinglock 110 may be formed of any suitable material, the sealing lock 110shown is made of a resilient material to allow it open and be compressedagainst the heart tissue. The resilience of the material providesbenefits both in helping to seal the opening created as well hasresiliently holding the wall of the ventricle in the modifiedconfiguration.

In alternate embodiments, an adhesive, bonding or other mechanical orchemical means may be used to connect the sealing lock 110 to the anchor104.

If desired, the tip of the hollow needle 102 may be equipped with apressure sensor to guide the practitioner to know if the tip is in theleft ventricle, septum or the right ventricle by sensing the pressure.The hollow needle 102 may also be equipped with electrical sensor (EKG,Monophasic Action Potential) to sense if the puncture sight is theviable tissue or infracted tissue.

FIGS. 2A-C show an alternate procedure of that shown in FIGS. 1A-C. Inthis method, the distal end of the anchor is again guided to theanterior wall of the left ventricle. The tip of the curved needle 102 isthen guided through the septum and into the right ventricle. In theconfiguration shown in FIG. 2A, the introducer 102 also extends throughthe anterior wall of the right ventricle. Once deployed, the distal tipof the anchor 104 is outside the right ventricle and the proximal tip isoutside the left ventricle.

FIGS. 3A-B show a method and device for left ventricular reconstruction120 using a right ventricular approach. In this version, a curved needle122 forms the distal tip of the anchor. The curved needle 122 isinserted through the anterior wall and into the right ventricle, throughthe septum, and through the anterior wall of the left ventricle. Thebody of the anchor follows the curved needle 122 and is fed throughuntil the proximal stop 124 engages the anterior surface of the rightventricle. The anterior wall of the left ventricle is pressed inwardover the body of the anchor. A distal sealing stop 126 is threaded overthe anchor 120 and slid in place against the anterior surface of theright ventricle. The heart tissue may be pressed inward to fold the wallof the heart prior to the placement of the sealing stop 126 or thesealing stop 126 may be used to manipulate the heart tissue. A pluralityof barbs or protrusions 128 extend from the surface of the anchor body.The barbs 128 help hold the heart tissue in place. The curved needle 122and the excess portion of the distal end of the anchor may be removed.This may be done before or after the distal sealing stop 126 has beenplaced.

The transventricular anchor may be temporarily or permanently implanted.A temporary implantation may be beneficial to test the effectiveness ofthe treatment for a particular patient. Other surgical procedures mayonly require a temporary reduction in ventricle volume. For thesesituations, the device may be removable. To remove the device, it may becut or broken or another release mechanism may be used to allow forremoval of the device. Once the efficacy is confirmed for a patient, apermanent version of the anchor could be implanted. Alternately, asemi-permanent or permanent device may be implanted initially.

The transventricular anchor may be used to treat medical conditionsincluding left ventricular hypertrophy. While the examples given arespecific to performance of reconfiguration of the left ventricle. Otherprocedures could also be performed to reduce the internal volume ofother bodily structures, including other chambers of the heart, gastricsystem, etc.

The present invention may be deployed during an open-heart procedure orit may be one using minimally invasive techniques using catheter systemsand/or ports formed between the ribs.

Many features have been listed with particular configurations, options,and embodiments. Anyone or more of the features described may be addedto or combined with any of the other embodiments or other standarddevices to create alternate combinations and embodiments.

Although the invention has been fully described above, in relation tovarious exemplary embodiments, various additions or other changes may bemade to the described embodiments without departing from the scope ofthe present invention. Thus, the foregoing description has been providedfor exemplary purposes only and should not be interpreted to limit thescope of the invention.

What is claimed is:
 1. A method of performing ventricular reconstructionof a heart, the method comprising: passing an introducer from outsidethe heart through a wall of the heart; passing the introducer through aseptum of the heart; inserting an anchor through the wall and throughthe septum of the heart, the anchor being coupled with a distal end ofan elongate body that extends from the anchor through the wall andseptum of the heart, wherein the anchor is inserted through the wall andseptum ahead of an entire length of the elongate body; extracting theintroducer through the septum and the wall of the heart and removing theintroducer to outside the heart; subsequent to extracting the introducerthrough the septum and the wall of the heart, placing a sealing memberover the elongate body, the sealing member being unconnected from theanchor and being slidable distally along the elongate body toward theanchor, wherein an interaction between the sealing member and theelongate body resists movement of the sealing member along the elongatebody away from the anchor; tensioning the elongate body to slide thesealing member distally along the elongate body and into engagement withthe wall and to press the wall inward to engage the wall and the septum;and securing the wall and septum via the interaction between the sealingmember and the elongate body.
 2. The method of claim 1, wherein securingthe wall and septum reduces a volume of a left ventricle of the heart.3. The method of claim 1, wherein the interaction between the sealingmember and the elongate body comprises the sealing member engaging oneor more protrusions extending from the elongate body.
 4. The method ofclaim 1, wherein the sealing member comprises a resilient materialadapted to resiliently press against an exterior surface of the wall ofthe heart.
 5. The method of claim 1, further comprising removing aportion of a proximal end of the elongate body that extends proximallyfrom the sealing member.
 6. The method of claim 1, wherein the anchor istemporarily implanted.
 7. The method of claim 1, further comprisingdeploying one or more arms of the anchor within a chamber of the heart,the one or more arms being engageable with the septum after deployment.8. The method of claim 7, wherein the one or more arms are pivotallydeployable from the elongate body.
 9. The method of claim 1, wherein theintroducer comprises a hollow bore and the step of inserting the anchorthrough the wall and through the septum of the heart comprises insertingthe anchor through the hollow bore of the introducer.
 10. A method ofperforming ventricular reconstruction of a heart, the method comprising:passing an introducer from outside the heart through a wall of theheart; passing the introducer through a septum of the heart; insertingan anchor through the wall and through the septum of the heart, theanchor being coupled with a distal end of an elongate body that extendsfrom the anchor through the wall and septum of the heart; deploying oneor more arms of the anchor within a chamber of the heart, the one ormore arms being engageable with the septum after deployment; extractingthe introducer through the septum and the wall of the heart; subsequentto extracting the introducer through the septum and the wall of theheart, placing a sealing member over the elongate body, the sealingmember being slidable distally along the Elongate body and beingconfigured to interact with the elongate body to resist movement of thesealing member along the elongate body away from the anchor; tensioningthe elongate body to engage the wall and the septum; and securing thewall and septum via an interaction between the sealing member and theelongate body; wherein the introducer comprises a hollow bore andwherein the anchor and an entire length of the elongate body areinserted through the hollow bore of the introducer to insert the anchorand elongate body through the wall and the septum of the heart.
 11. Themethod of claim 10, wherein the interaction between the sealing memberand the elongate body comprises engaging one or more protrusionsextending from the elongate body.
 12. The method of claim 10, whereinthe sealing member comprises a resilient material adapted to resilientlypress against an exterior surface of the wall of the heart.
 13. Themethod of claim 10, further comprising removing a portion of a proximalend of the elongate body that extends proximally from the sealingmember.
 14. The method of claim 10, wherein the one or more arms arepivotally deployable from the anchor.
 15. A method of performingventricular reconstruction of a heart, the method comprising: passing anintroducer from outside the heart through a wall of the heart, theintroducer comprising a proximal end and a distal end with a hollow boreextending between the proximal end and the distal end; passing theintroducer through a septum of the heart so that the introducer ispositioned through the wall and the septum of the heart; inserting ananchor and an elongate body axially through the hollow bore of theintroducer and through the wall and septum of the heart, the anchor andelongate body being inserted through the hollow bore from the proximalend of the introducer to the distal end of the introducer and the anchorbeing coupled with a distal end of the elongate body such that theelongate body extends from the anchor through the wall and septum of theheart; removing the introducer; placing a sealing member over theelongate body, the sealing member being unconnected from the anchor andbeing slidable distally along the elongate body toward the anchor,wherein an interaction between the sealing member and the elongate bodyresists movement of the sealing member along the elongate body away fromthe anchor; tensioning the elongate body to engage the wall and theseptum; and securing the wall and septum via the interaction between thesealing member and the elongate body.
 16. The method of claim 15,wherein the interaction between the sealing member and the elongate bodycomprises engaging one or more protrusions extending from the elongatebody.
 17. The method of claim 15, wherein the sealing member comprises aresilient material adapted to resiliently press against an exteriorsurface of the wall of the heart.
 18. The method of claim 15, furthercomprising removing a portion of a proximal end of the elongate bodythat extends proximally from the sealing member.
 19. The method of claim15, further comprising deploying one or more arms of the anchor within achamber of the heart, the one or more arms being engageable with theseptum after deployment.